Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00148629|
Recruitment Status : Unknown
Verified September 2005 by Cornell University.
Recruitment status was: Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : November 18, 2005
|Condition or disease||Intervention/treatment||Phase|
|Anemia Low Birth Weight Neonatal Mortality||Drug: multivitamin, mebendazole||Phase 3|
This is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women. The specific aims are:
Aim 1: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the prevention of severe anemia among pregnant Zanzibari women. This aim will be achieved through a pre-post intervention comparison.
Aim 2: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women.
Aim 3: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the cure of severe anemia among pregnant Zanzibari women.
Aim 4: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||2500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care|
|Study Start Date :||April 2004|
- Incidence of severe anemia (Hb < 7 g/dL)
- Cure of severe anemia
- Infant birth weight
- Neonatal mortality
- Neonatal morbidity
- Blood loss during delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148629
|Public Health Laboratory "Ivo de Carneri"|
|Wawi, Zanzibar, Tanzania|
|Principal Investigator:||Rebecca J Stoltzfus, PhD||Cornell University|
|Principal Investigator:||James M Tielsch, PhD||The Johns Hopkins Bloomberg School of Public Health|